Dual Trigger for Elective Fertility Preservation

Dual Trigger vs. GnRH-a Trigger for Elective Fertility Preservation. A randomized controlled trial. - DUAL-T trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002467-22-ES

Enrollment

100

Registered

2021-06-11

Start date

2021-07-02

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This study is a randomized controlled, superiority trial comparing the number of MII oocytes following final follicle maturation with dual trigger (250 µg rhCG + 0.2mg Triptorelin) or GnRH-a trigger (0.2mg Triptorelin) in women undergoing elective fertility preservation.

Interventions

Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable Pharmaceutical Form: Solution for injection Trade Name: Decapeptyl diario 0,1 mg polvo y disolvente para solución inye

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • AFC 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Medically indicated fertility preservation • AFC = 20 • Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria • FSH = 20 • History of untreated autoimmune, endocrine or metabolic disorders • Contraindication for hormonal treatment • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol.;Secondary Objective: To compare the dual trigger and GnRH-a trigger regarding: 1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, Estradiol, progesterone) 3. Incidence of OHSS;Primary end point(s): To compare the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation.;Timepoint(s) of evaluation of this end point: About 34-36 hours thereafter oocyte pick-up will be performed.	—

Measure

Time frame

Main Objective: To compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol.;Secondary Objective: To compare the dual trigger and GnRH-a trigger regarding: 1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, Estradiol, progesterone) 3. Incidence of OHSS;Primary end point(s): To compare the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation.;Timepoint(s) of evaluation of this end point: About 34-36 hours thereafter oocyte pick-up will be performed.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, estradiol, progesterone) 3. Incidence of OHSS;Timepoint(s) of evaluation of this end point: Total number of oocytes retrieved:About 34-36 hours thereafter oocyte pick-up will be performed. Endocrine profile on the day after trigger Incidence of OHSS: Untul 7 days after oocyte pick-up	—

Measure

Time frame

Secondary end point(s): 1. Total number of oocytes retrieved 2. Endocrine profile on the day after trigger (FSH, LH, estradiol, progesterone) 3. Incidence of OHSS;Timepoint(s) of evaluation of this end point: Total number of oocytes retrieved:About 34-36 hours thereafter oocyte pick-up will be performed. Endocrine profile on the day after trigger Incidence of OHSS: Untul 7 days after oocyte pick-up

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Countries

Spain

Contacts

Public ContactUnidad de Apoyo a la Investigación

Fundacion Santiago Dexeus Font

nacrod@dexeus.com34932274700

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026